Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 19, 2023
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test r…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Church & Dwight Inc recalled Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of con… - a moderate-severity action.
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of con… was recalled by Church & Dwight Inc in April 19, 2023. Reason: Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There …. Check the official notice for the remedy. Verify recall #Z-1350-2023 with the FDA Devices before acting.
The recall
Church & Dwight Inc issued this moderate-severity FDA Devices recall-Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There ….
- Moderate
- severity level
- Class II
- classification
- April 19, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1350-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1350-2023) was formally reported on April 19, 2023, with the manufacturer initiating the action on January 25, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Church & Dwight Inc is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 780000 downloads.
The documented reason for this recall is: Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the… Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
780000 downloads
Related Recalls
6
3 from same agency
Product description
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
Reason for recall
Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1350-2023 |
| Date reported | April 19, 2023 |
| Date initiated | January 25, 2023 |
| Recalling firm | Church & Dwight Inc |
| Firm location | Princeton, NJ |
| Affected scope | 780000 downloads |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1350-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad). Recalled by Church & Dwight Inc. Units affected: 780000 downloads.
Why was this product recalled? ▼
Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1350-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1350-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 19, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.